Sulfasalazine Tablets USP

1. Product Introduction

Salacir Sulfasalazine Tablets USP 500 mg are uncoated oral tablets containing sulfasalazine, an anti-inflammatory medicine used in the management of ulcerative colitis and certain forms of inflammatory arthritis, including rheumatoid arthritis.

Healthy Life Pharma Pvt. Ltd. is identified as the manufacturer and Healthy Inc as the exporter in the supplied product information. Contract manufacturing, regulatory support and destination-market availability should be confirmed directly with the company. The supplied composition specifies uncoated tablets; enteric-coated or delayed-release versions are not confirmed for this product.

2. Product Specifications

3. Manufacturing Technology

Sulfasalazine is a strongly colored active pharmaceutical ingredient. Manufacturing controls may include dust containment, validated cleaning procedures, blend uniformity checks, suitable granulation and tablet compression controls.

Formulation distinction: The supplied Salacir specification is an uncoated tablet. Delayed-release or enteric-coating processes should not be attributed to this SKU without a separate approved formulation record. Specific equipment, manufacturing suites, coating polymers and packaging formats require facility-level confirmation.

4. Quality Assurance

Quality assessment should follow the applicable USP monograph and approved finished-product specifications, including identity, assay, uniformity of dosage units, dissolution/disintegration where applicable, related substances and stability.

Batch-specific acceptance limits and test results should be taken from the approved specification and certificate of analysis (COA). No unverified dissolution percentages, assay limits or shelf-life claims are presented here as guaranteed product attributes.

5. Therapeutic Uses and Mechanism

Sulfasalazine contains a linkage between 5-aminosalicylic acid (5-ASA) and sulfapyridine. Intestinal bacteria cleave this linkage in the colon. Its anti-inflammatory and immunomodulatory effects are used for ulcerative colitis and inflammatory joint disease.

• Ulcerative colitis: Used for treatment and maintenance of remission under clinician supervision.
• Rheumatoid arthritis: A conventional DMARD used to control inflammation and symptoms.
• Other indications: Depend on the approved label, formulation and local prescribing guidance.

Sulfasalazine is not a routine medicine for undiagnosed diarrhoea, which can have infectious or other causes.

6. Export and Regulatory Support

For procurement, contract manufacturing or international registration, request the current product dossier, market-specific registration status, batch COA, stability data, approved artwork and available pack sizes.

WHO-GMP, COPP, Free Sale Certificate, CTD/ACTD dossier availability, exporter status and shipping terms must be verified against current documents before being advertised or relied upon.

Contact the export team or call +91 7710003340.

7. Frequently Asked Questions

Q: What does Salacir contain?
A: Each uncoated tablet contains Sulfasalazine USP 500 mg.

Q: Is this an enteric-coated tablet?
A: No. The supplied Salacir product composition identifies an uncoated tablet. Enteric-coated products are distinct formulations.

Q: What conditions is sulfasalazine used for?
A: It is used for ulcerative colitis and certain inflammatory arthritis conditions, as directed by a healthcare professional.

Q: Can it discolor urine or affect contact lenses?
A: Yellow-orange discoloration of urine or skin can occur, and soft contact lenses may become stained.

Q: Who should avoid it?
A: Patients with relevant sulfonamide or salicylate hypersensitivity, certain obstructions or porphyria require particular caution; consult the approved prescribing information.

8. Dosage and Administration

For registered medical practitioners and patient reference only. Dosage varies by diagnosis, age, response, tolerability and local product labeling. Clinicians commonly start with lower doses and adjust gradually to reduce gastrointestinal adverse effects.

Take according to the prescriber’s directions, generally with food and adequate fluids. Do not substitute uncoated and delayed-release tablets without medical advice. Do not start, stop or adjust treatment independently.

9. Side Effects and Precautions

• Common: Nausea, abdominal discomfort, headache, appetite loss and yellow-orange discoloration of urine.
• Serious: Severe skin reactions, liver injury, blood cell disorders and hypersensitivity reactions require urgent medical evaluation.
• Monitoring: Complete blood counts, liver tests and kidney function are typically monitored before and during treatment.
• Fertility: Reversible reduction in sperm count may occur in some men.
• Contraindications/interactions: Review sulfonamide/salicylate allergies, porphyria, bowel or urinary obstruction, and concurrent medicines with the prescriber.

Seek urgent medical attention for severe rash, fever, sore throat, unusual bruising, jaundice or breathing difficulty.

10. Storage Instructions

Store in the original, tightly closed packaging, protected from excess moisture and light, according to the approved product label. Keep out of reach of children.

The exact storage temperature, pack configuration and expiry period must be confirmed from the approved label and batch-specific documentation; a 36-month shelf life has not been independently established for this SKU.